FDA Adverse Event
Injury
Summary report: N
MEDACTA KNEE IMPLANTS
MDR report key: 5396333
·
Received January 28, 2016
Report
- Report Number
- 3005180920-2016-00004
- Event Type
- Injury
- Date Received
- January 28, 2016
- Date of Event
- December 29, 2015
- Report Date
- April 18, 2016
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE SURGEON SUBMITTED A REPORT THROUGH MEDACTA WEBSITE WITHOUT ANY INFORMATION ON THE IMPLANT; HE ONLY MENTIONED MYKNEE (K093806) THAT IS AN INSTRUMENT USED DURING THAT CASE. UP TO (B)(6) 2016 WE WERE NOT ABLE TO GET MORE INFORMATION FROM HIM, EVEN IF THERE WERE MULTIPLE ATTEMPTS TO DO IT.
Additional Manufacturer Narrative · 1
ON 22 MARCH 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INTIAL REPORT. ON 23 MARCH 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.
Description of Event or Problem · 1
THE PATIENT WENT TO THE SURGEON WITH TIBIAL SUBLUXES POSTERIORLY DURING FLEXION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 53635 | MEDACTA KNEE IMPLANTS | TOTAL KNEE IMPLANT | JWH | MEDACTA INTERNATIONAL SA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Other |